Kornimate/medical-research-clean huggingface dataset:
next-generation, integrative, and personalized risk assessment to prevent recurrent heart failure events: the oracle study

Conditions: Heart Failure

Summary: the aim of this study is to develop and validate an improved, comprehensive risk assessment algorithm integrating blood rna-based biomarkers, clinical, and patient-centered data and to assess the incremental predictive value (discrimination and reclassification) compared to a traditional risk model (change in the c-statistics for prediction of the primary endpoint).

the oracle study is a multicenter, observational, prospective, cross-sectional and longitudinal study integrated by 3 different cohorts for 1) rna biomarker discovery (60 nested case-control sample), 2) model derivation (516 nested case-control sample) and 3) external validation (new prospective cohort of 558 consecutive patients recruited in 4 hospital centers) according to a tripod statement type 3 analysis. in total 1134 consecutive patients with a hf hospitalization or urgent hf visit \< 30 days before inclusion and followed for 6 months will be studied. this study include the discovery of novel rna-based biomarkers using next-generation sequencing technology to define and validate a new biomarker set and clinical and patient-centered risk determinants definition. a new model will be constructed; training and internal validation in the derivation cohort using machine learning methods, and finally an external validation of the new next generation integrative risk assessment model will be performed.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * patients with a recent (\<30 days) acute decompensation of hf requiring intravenous diuretic therapy (either hospitalized or in ambulatory care) or intensification of oral diuretics (ambulatory care). * hf diagnosis according to european society of cardiology (esc) criteria. * written informed consent * patients receiving oral standard medication for chronic hf. exclusion criteria: * age\<18 years old. * death before hospital discharge. * the patient is unable or unwilling to give the informed consent to participate. * unstable patients with signs of fluid overload or low cardiac output at the moment of enrollment.

Keywords: machine learning multi-omics approaches outcomes research patient-centered information
neural mechanisms underlying alcohol induced disinhibition

Conditions: Alcoholism

Summary: forty 18-year-old social drinkers will be selected from the sample tested in specific aim 1 ("prospective assessment of adolescent drinking trajectories with computer-assisted self-administration of ethanol (case)"; clinicaltrials.gov identifier: nct01063166). the functional magnetic resonance imaging blood-oxygen-level-dependent (fmri bold) activity related to disinhibition measured with the stop signal task will be assessed during a continuous infusion of alcohol, clamping the arterial breath alcohol concentration (abac) at 60 mg% for approximately one hour. it will be examined whether this fmri bold activity is associated with the initial drinking trajectories and the alcohol consumption at age 18 and at age 20 identified in specific aim 1. furthermore, fmri will be used with the taylor aggression paradigm to determine which brain areas mediate increased physical aggression during the same continuous infusion of alcohol as described above. all participants will undergo an alcohol and a placebo fmri session.


Eligibility criteria:
inclusion criteria: * male and female caucasian volunteers aged 18 years/0 months to 19 years/11 months; * written informed consent by the subject; * habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval; * at least one prior experience of alcohol intoxication * being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms; * effective contraception in female participants; * consenting to abstain from any illegal substance use for 2 weeks prior to participation; * living within 15 km (9.5 miles) from downtown dresden; * sufficient information concerning alcohol use in both parents and in at least four second-degree relatives exclusion criteria: * prior medical treatment due to alcohol use; * current or prior history of any serious disease, including cns, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse; * current history of axis-i psychiatric illness, including premenstrual dysphoric disorder; * current or prior history of alcohol-induced flushing reactions; * positive urine screen for cannabinoids, cocaine, amphetamines, opiates, or benzodiazepines; * light or non-drinkers: averaging less than 2 standard drinks per week in the preceding two months; * intention to become pregnant * pregnancy or positive urine pregnancy screening or breast-feeding; * any alcohol intake on the test day or the day before; * use of medications known to interact with alcohol within 2 weeks of the study; * positive hepatitis or hiv at screening, provided the subject consented to these tests * any conditions posing safety issues with the fmri scan, such as ferromagnetic implants, cardiac pacemakers or insulin pumps
surface treatment of the dental implant on the osseointegration

Conditions: Dental Implants; Surface Treatment

Summary: dental implants have become a widely accepted treatment modality for the replacement of missing single or multiple teeth in the recent years. in order to meet patients' needs for shorter treatment times and the necessity of dealing with more challenging clinical situations, implants and implant therapies have undergone continuous improvement to improve the function and longevity of the implants. recently the constant search for improvements in modern implant have been focused on surface modifications so a new era of surface treatment have been showed up; the chemically modified hydrophilic surfaces.


Eligibility criteria:
inclusion criteria: * missing mandibular posterior teeth. * good oral hygiene (plaque index less than 10 %) * good compliance to the treatment. * participants are free from local or systemic disease * willingness and ability to commit to follow-up placement. * adequate bone height and width to accommodate implant placement and sufficient keratinzed mucosa. * at least 3months after tooth extraction * sufficient interocclusal distance exclusion criteria * presence of persistent and unresolved infection in the implant site * parafunctional habits. * heavy smokers. * uncontrolled systemic disease that impedes bone healing
project sexual awareness for everyone (safe)

Conditions: Sexually Transmitted Disease; Secondary Prevention; Behavioral Modification; Public Health

Summary: this trial randomizes young mexican american and african american women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.

participants are interviewed, examined, and offered treatment at 0, 6, 12 months and as necessary.

Eligibility criteria:
inclusion criteria: * mexican american, * 14 - 45 years old, * english speaking, * non-viral sexually transmitted infection exclusion criteria: * non-english speaking, * viral sexually transmitted infection

Keywords: sexually transmitted infections secondary prevention cognitive behavioral intervention
prosa: prolactin, sex hormones, growth and metabolic biomarkers in children and adolescents on antipsychotics

Conditions: Hyperprolactinemia; Puberty Disorders; Metabolic Syndrome; Growth Disorders; Antipsychotics and Neuroleptics Toxicity

Summary: the objectives of this study are: 1. to determine the prevalence and degree of hyperprolactinemia in children and adolescents aged 7-18 years receiving antipsychotic medications 2. to determine the associations between serum-prolactin and sex hormones / metabolic biomarkers/ clinical symptoms in this population. if clinically relevant associations are found: to determine a potentially existing "no harm" serum-prolactin threshold 3. to determine associations between previous cumulative prolactin-exposure and current pubertal development / growth


Eligibility criteria:
inclusion criteria: * • in daily treatment with antipsychotic medication belonging to anatomical therapeutic chemical (atc) group n05a (except n05an lithium) for a minimum duration of 3 months prior to inclusion exclusion criteria: * eating disorder * medical treatment to change sex * pregnancy or lactation
effects of anti-pd1 adjuvant checkpoint blockade immunotherapy on atypical/dysplastic nevi

Conditions: Melanoma

Summary: this study will examine the impact of anti-programmed cell death 1 (pd1) therapy given in the approved adjuvant therapeutic regimens upon the morphologic, histopathologic, molecular and immunologic as well as genomic features of atypical/dysplastic nevi (a/dn) in patients with a prior documented melanoma of stages iib, iic, iiia, iiib, or iiic and concurrent presence of two or more atypical nevi.

given the established efficacy of anti-pd1 therapy as an adjuvant treatment in both advanced nodal and earlier stage deep primary node negative melanoma, this study hypothesizes that anti-pd1 therapy may provide a basis for effective therapeutic prevention. to study if anti-pd1 therapy can help prevent the development of melanoma, this study will examine its effects upon atypical/dysplastic nevi, which are well established as non-obligate pre-cursor lesions that are markers of increased risk of melanoma. this single agent, adjuvant study will evaluate the impact of adjuvant anti-pd1 therapy on morphology, histopathology, immunologic/molecular features, and gene expression of atypical/dysplastic nevi present in patients with stage iib-iii melanoma. this study aims to determine if anti-pd1 therapy will increase cd8 t cell responses to melanoma antigens, resulting in immune surveillance and anti-tumor immune responses within a/dn. it postulates that in response to anti-pd1 therapy, the aggregate pigmentation of total nevi including atypical/dysplastic nevi and benign melanocytic nevi will decrease with a measurable morphologic response. this study also asserts that there will be histopathologic changes within a/dn including increased density of immune infiltrate and increased presence of regression features. increased anti-tumor immune response measured by increased cd8, ifn-y, and pd-1 expression within nevi is anticipated, along with a decrease in genes involved in pathways of melanomagenesis, pigmentation, and inflammation.

Eligibility criteria:
inclusion criteria: 1. subjects must have at least two atypical nevi of ≥ 4 mm diameter. 2. subjects must have a current documented history of melanoma. 3. subject must be ≥ 18 years and if female of childbearing potential, must agree to practice effective contraception per institutional soc if sexually active. 4. subjects will have been deemed candidates for adjuvant therapy with single agent anti-pd1 therapy. 5. subjects must give written informed consent to participate in this study with consent signed and dated prior to entry into trial. exclusion criteria: 1. patients with non-malignant diseases or indications that would preclude the administration of anti-pd1 therapy such as significant immune suppression or active autoimmune disease requiring disease modifying, immunosuppressive therapy, will be ineligible. 2. patients who have previously received anti-pd1 therapy 3. patients with history of other active, non-melanoma cancers 4. patients who are receiving other anti-neoplastic therapy.

Keywords: anti-pd1 therapy immune checkpoint blockade dysplastic nevi braf and nras mutations
role of magnetic resonance enterography for predicting peritoneal cancer index

Conditions: Hyperthermic Intraperitoneal Chemotherapy; Cytoreductive Surgery; Peritoneal Carcinomatosis

Summary: this is a prospective observational study which will recruit 90 participants over a three-year period to investigate whether adding magnetic resonance imaging and enterography to routine computed tomography study can better predict the extend of peritoneal carcinomatosis over computed tomography alone.

hyperthermic intraperitoneal chemotherapy (hipec) is a new option for patients with peritoneal carcinomatosis and the effectiveness of hipec depends on the extend of disease. currently, pre-operative imaging peritoneal cancer index (pci) is used to predict the intraoperative tumor extend and completeness of cytoreduction. however, the investigators' previous study and literature review show that imaging pci usually underestimated intraoperative pci, resulting in subsequent open-close operation. the investigators hypothesize that magnetic resonance imaging (mri) is a better predictor of the intra-operative pci than computed tomography (ct), and mr enterography can better represent tumor deposits in the small intestine. this study aims to test whether the addition of mri and mr enterography to ct study improves the prediction performance of the intraoperative pci and completeness of optimal cytoreduction over ct alone.

Eligibility criteria:
inclusion criteria: * patients with peritoneal carcinomatosis diagnosed by computed tomography * schedule for operation at our institute exclusion criteria: * age \< 20 years old * renal function impairment or acute renal failure * contraindications for magnetic resonance imaging * primary tumor not origins from colorectal cancer, gastric cancer or ovarian cancer

Keywords: hyperthermic intraperitoneal chemotherapy cytoreductive surgery peritoneal cancer index magnetic resonance enterography
real world utilization and outcomes with dacomitinib first line treatment for egfr mutation-positive advanced non small cell lung cancer among asian patients - a multi center chart review

Conditions: Lung Cancer

Summary: this is a longitudinal, consecutive case-series, multi-center study with mixed prospective and retrospective data collection. data will be collected from eligible adults with egfr mutation-positive advanced non-small cell lung cancer (nsclc) treated with dacomitinib as first-line therapy from the date of advanced nsclc diagnosis to the date of death, lost to follow-up, withdrawal of consent or end of study, whichever occurs first.


Eligibility criteria:
inclusion criteria: * adult (aged ≥18 years) with histology-confirmed advanced nsclc (tnm stage iiib-iv); * presence of any egfr-activating mutation (exon 19 deletion or exon 21 l858r substitution) or other uncommon egfr mutations prior to anti-cancer treatment; * initiating dacomitinib as first-line treatment after confirmation of egfr-mutation status (ie, no prior treatment with other egfr tki or systemic therapy); exclusion criteria: * enrolled in any interventional clinical study or trial (however, patients enrolled in non-interventional, real world study may still be included).
stereotactic ablative body radiation therapy for patients with primary renal cancer

Conditions: Renal Cancers

Summary: the goal of this phase ii clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.

current treatment options for primary renal cancer include surgery or ablative techniques-all are invasive or minimally invasive options. the completely noninvasive treatment option of stereotactic radiation therapy (sabr), which has become standard of care in many cancer sites, has not been explored for primary renal cancer. with multiple technological advances, it is now feasible to safely treat a moving intra-abdominal tumor such as that in a kidney. this proposed clinical trial evaluates the efficacy of sabr in treating patients with early renal cancers. growing renal masses will first be biopsied to confirm the diagnosis of renal cancer. patients will then undergo treatment with sabr of 3-5 fractions completing within three weeks. treatment response will be evaluated using sequential mri scans and a second tumor biopsy one year after treatment. monitoring of treatment toxicity and kidney function will also be performed.

Eligibility criteria:
inclusion criteria * age ≥ 18 years. * renal mass ≤ 5cm * the treating renal mass must be ≤ 5cm. other renal masses (cysts etc.) of any size will not make the subject ineligible * biopsy proven renal neoplasm * all histology of renal cancers are included including oncocytoma * growth of renal mass \>2mm in radiographic scans must be demonstrated within a one year period. * ability to understand and the willingness to sign a written informed consent. * subject is able to undergo either an mri or administration of contrast agent for ct * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * has not undergone a hysterectomy or bilateral oophorectomy; or * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). exclusion criteria: * subject has received any treatment for the treating renal mass; such as rfa or cyroablation. * if other renal masses received rfa or cryoablation or surgery, then these patients are eligible. * subjects received previous abdominal radiation * evidence of metastatic disease, unless disease-free for ≥ 3 years prior to registration, (non-melanomatous skin cancer and in-situ cancers are okay). * female subjects who are pregnant or planning to become pregnant during the course of sabr.

Keywords: renal cancer
cold oxygen lung preservation and ventilation with the "angel cooler"

Conditions: Lung Diseases

Summary: the objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (o2) concentration and ventilation with positive end expiratory pressure (peep) to keep lungs cooled at 4-8 degrees celsius, with continuous o2 concentration of 100% and inflated with a peep of 8-10 during the entire cold ischemic period.

the angel lung cooler is a lung preservation method for transplantation. the device has temperature and airway pressure sensors that assess the oxygen temperature in the airways to confirm during the entire preservation time that desired airway temperatures (between 8 and 10 oc) and mean airway pressure to keep the lungs inflated during transportation is optimized. for the purposes of the trial, the angel cooler will be in the operating room at time of transplant when both of the lungs are explanted. the explanted lungs (those removed and not the donor lungs) will be connected to the cooler to determine inflation and temperature changes of the lungs. this procedure will take approximately 5 - 20 minutes. the lungs will then be disconnected from the cooler and then returned to the back table for transport to the pathology department. as part of standard procedures, the lungs remain in the operating room for a few hours before they are transported to the pathology department.

Eligibility criteria:
inclusion criteria: * age at least 18 years * subjects who have signed universal consent are eligible for participation. * subjects willing to sign the universal consent for the use of their lungs in this study. exclusion criteria: • explanted lungs of those who have not signed the universal consent (uc) or who have declined participation in the uc will be excluded.
4xl study - obesity surgery in adolescence

Conditions: Obesity, Morbid

Summary: the purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.

the study has two intervention arms: experimental: group a surgery; laparoscopic gastric bypass active comparator: group b patients from child obesity registry of vestfold who get standard conservative treatment in a multidisiplinary team at morbid obesity center. all patients are referred to morbid obesity center from other hospitals or general practionairs in norway. the procedure will take place at the vestfold hospital trust the participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the morbid obesity center. total follow-up time is ten years.

Eligibility criteria:
inclusion criteria: * between 13 and 18 years of age at inclusion * tanner stage 4-5 * bmi \> 40 kg/m2 or bmi \> 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor) * at least one year multidisciplinary treatment completed exclusion criteria: * tanner stage \< 4 * substantial risk for lack of compliance * obesity syndrome (e.g., prader willi syndrome) * obesity related to brain damage * serious general disease * monogenic obesity

Keywords: adolescents gastric bypass quality of life mental health lifestyle
frailty score assessment for elderly patients undergoing cardiac resynchronization therapy

Conditions: Heart Failure

Summary: background: the cardiac resynchronization therapy (crt) has been shown to improve symptoms and outcome of patients with congestive heart failure (hf), and depressed left ventricular ejection fraction (lvef \< 35 %). the rate of non-responders to crt is estimated at 30 %. yet, the impact of frailty on the response to crt has not been studied, until now. purpose : to assess the impact of frailty in the elderly, on the response to crt.

methods : frailty is evaluated before implant ,and defined as \ 70 years age, selected for crt according to the esc 2013 guidelines. the response to crt, estimated at 9 months, is defined as an improvement of at least 5 % of the lvef and the absence of hf hospitalization or cardiovascular death.

Eligibility criteria:
inclusion criteria: * patients of \> 70 years age, * selected for crt according to the esc 2013 guidelines exclusion criteria: * patients included in other clinical trial which can interfere with the results of this one

Keywords: frailty heart failure cardiac resynchronization therapy